Type 2 DiabetesNCT01689051
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
A study testing human glucagon-like peptide 1 (7-36)amide and human glucagon-like peptide 1 (9-36)amide in people with Type 2 Diabetes and Blod Pressure, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Blod Pressure, Glucagon-like Peptide-1
- What is being tested?
- human glucagon-like peptide 1 (7-36)amide and human glucagon-like peptide 1 (9-36)amide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- T2DM according to WHO's criteria (only T2DM subjects)
Who cannot join
- Anemia
- T1DM
- Severe liver or renal disease
- Severe heart disease
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated.
Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate.
Read more
Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate whether GLP-1 enhances the absorption of sugar in the leg.
The investigators also examines whether these effects are greater in people with diabetes then in healthy.
- Being tested
- human glucagon-like peptide 1 (7-36)amide, human glucagon-like peptide 1 (9-36)amide
- Keywords
- Type 2 diabetes, Blod pressure, Glucagon-like peptide-1, Human physiology, Blood flow
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human glucagon-like peptide 1 (7-36)amideOther
human glucagon-like peptide 1 (9-36)amideOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | Not described Receives: Other: human glucagon-like peptide 1 (7-36)amide; Other: human glucagon-like peptide 1 (9-36)amide |
| Patients with type 2 diabetes | Active comparator | Not described Receives: Other: human glucagon-like peptide 1 (7-36)amide; Other: human glucagon-like peptide 1 (9-36)amide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral artery blood flow
Secondary outcomes (1)
Leg glucose uptake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen
- Investigators
- Jacob C Sivertsen, MD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689051
- Sponsor's protocol ID
- 1-Sivertsen
- Status last verified
- Jan 2014
- First submitted
- 17 Sep 2012
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01689051
- Acronym / sponsor ID
- 1-Sivertsen
- Keywords
- Type 2 diabetes, Blod pressure, Glucagon-like peptide-1, Human physiology, Blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated.
Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate.
Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate whether GLP-1 enhances the absorption of sugar in the leg.
The investigators also examines whether these effects are greater in people with diabetes then in healthy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Active comparator | Other: human glucagon-like peptide 1 (7-36)amide, Other: human glucagon-like peptide 1 (9-36)amide |
| Patients with type 2 diabetes | Active comparator | Other: human glucagon-like peptide 1 (7-36)amide, Other: human glucagon-like peptide 1 (9-36)amide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- T2DM according to WHO's criteria (only T2DM subjects)
Key exclusion criteria (5 listed)
- Anemia
- T1DM
- Severe liver or renal disease
- Severe heart disease
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human glucagon-like peptide 1 (7-36)amide | Other | Healthy subjects, Patients with type 2 diabetes |
| human glucagon-like peptide 1 (9-36)amide | Other | Healthy subjects, Patients with type 2 diabetes |
Primary outcome
Femoral artery blood flow
1 secondary outcome
Leg glucose uptake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob C Sivertsen, MD principal investigator
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human glucagon-like peptide 1 (7-36)amide and human glucagon-like peptide 1 (9-36)amide in people with Type 2 Diabetes and Blod Pressure, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral artery blood flow. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.